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RecruitingNCT05809128Updated Mar 25, 2024

Multidisciplinary Approach to Breast Cancer Through the Study of Altered Transcriptomic and Immune Accompanied by the Identification of Extractable Markers From the Radiodiagnostic Bioimaging

An observational study in Breast Cancer Patients, sponsored by IRCCS SYNLAB SDN. Recruiting at 1 site in Italy. Open to female participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by IRCCS SYNLAB SDN · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
25 Years to 80 Years
Sex
Female
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Study summary

Prospective observational study for onco-immunologic characterization and by bioimaging of breast neoplastic tissue of patients operated for breast cancer

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Conditions studied

  • Breast Cancer Patients

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Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Breast cancer patients

Inclusion criteria

  • Clinical diagnosis of breast cancer.
  • patients 25 to 80 years of age

Exclusion criteria

Exclusion Criteria:

  • Patients who refuse to participate in the study;
  • Patients who do not fall within the age range mentioned above
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Interventions

  • Othersurgery for breast cancer and imaging test evaluations

    At the time of surgery, having completed the evaluation extemporaneous of the surgical piece, tissue samples will be collected to be stored from the material exceeding the completion of the patients' diagnosis. In addition, paramenters that can be extracted from radiodiagnostic images will be evaluated

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What researchers measure

Primary outcomes

  1. Multiparametric flow cytometry analyses of Custer of Differentiation (CD) proteins expression on tumor infiltrating lymphocytes

    The following phase of the study aims to go to evaluate the immunology of breast cancer patients compared with the control. In particular we will perfome an accurate characterization in flow cytometry of the cells present in the peripheral blood and of the immune component infiltrating the tumor (tumor infiltrating lymphocytes). The different components of tumor infiltrating lymphocytes will be assessed using the following antibodies: CD45 , CD8, CD4,CD3, HLA-DR, CD19 , CD 326 (EpCAM) ,CD56 , CD14 and CD16.

    Time frame: 1-24 months

  2. Analysis of gene expression profiles of cancer cells

    The following area of study is focused on the study by molecular biology of samples of cancerous and healthy tissue that will be possible to obtain from the subjects participating in the study. For that phase, the type of instrumentation will be determined according to the amount of nucleic acids extracted from the tissues. In fact, samples that will allow recovery of high amounts of RNA and with a good degree of purity will be able to be used for studies carried out with next generation sequencing such as, for example, Ion Torrent S5. In the case of samples in which the RNA is difficult to extract or of low quality, methods such as real time polymerase chain reaction (PCR) in multiplex mode

    Time frame: 1-24 months

  3. Extraction of features from radiological images to be used as biomarkers.

    Radiological images from High-field MRI, multilayer CT, hybrid systems such as PET-CT and PET-MRI will be use to extract quantitative parameters of the lesion and the other structures of interest. An automatic segmentation , or alternatively, a manual segmentation by an experienced radiologist or experienced nuclear physician will be performe.

    Time frame: 1-36 months

  4. Bioinformatics analysis

    The correlations between the cytofluorimetric characterization of TILs and the quantitative parameters extracted from radiological images will be performed using different software such as Graphpad or ER softwares.

    Time frame: 37-48 months

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Study locations

1 of 1 sites recruiting
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Registry details

Key details

Study ID
NCT05809128
Lead sponsor
IRCCS SYNLAB SDN
Responsible party
Sponsor
First posted
Apr 12, 2023
Start date
May 29, 2019
Primary completion
Jan 31, 2023
Completion
Jun 30, 2025 (estimated)
Last update
Mar 25, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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